Vertex Seeks FDA Green Light for Hepatitis C Drug; Chomps at the Bit For Fast Review

committed to working closely with the FDA to make telaprevir available as quickly as possible to the millions of people with hepatitis C who need new medicines to increase their chances for a viral cure.”

Hepatitis C is currently treated with pegylated interferon alpha and ribavirin, a combination therapy that causes flu-like symptoms, and which many patients consider worse than the disease itself, which can lie dormant for years. Telaprevir, an oral pill taken three times a day, is designed to attack the virus through a different mechanism than the other meds, as a member of the class of protease inhibitors. Vertex’s success at boosting viral cure rates and reducing the dependence on a widely loathed standard regimen has invited one serious late-stage competitor—Merck’s boceprevir. It has also helped inspire a wide array of other companies to attack the virus in various cocktail regimens with nucleoside inhibitors and non-nucleoside inhibitors, through a strategy that resembles the multi-drug approaches that are now standard therapy for HIV.

There are a lot of details about the safety and effectiveness of this drug in its main clinical trials, which I won’t attempt to repeat here. You can follow the links to our past coverage, including a Phase III results preview story in May, followed by the reports on the critical trials known as Advance, Illuminate, and Realize. You can also get a sense of Vertex’s vision for commercializing this drug through a profile of Emmens that ran back in January.

Author: Luke Timmerman

Luke is an award-winning journalist specializing in life sciences. He has served as national biotechnology editor for Xconomy and national biotechnology reporter for Bloomberg News. Luke got started covering life sciences at The Seattle Times, where he was the lead reporter on an investigation of doctors who leaked confidential information about clinical trials to investors. The story won the Scripps Howard National Journalism Award and several other national prizes. Luke holds a bachelor’s degree in journalism from the University of Wisconsin-Madison, and during the 2005-2006 academic year, he was a Knight Science Journalism Fellow at MIT.